• Title/Summary/Keyword: New Trial

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Maximum Tolerated Dose Estimate by Curve Fitting in Phase I Clinical Trial (제1상 임상시험에서 곡선적합을 이용한 MTD 추정법)

  • Heo, Eun-Ha;Kim, Dong-Jae
    • Communications for Statistical Applications and Methods
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    • v.18 no.2
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    • pp.179-187
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    • 2011
  • The purpose of a Phase I clinical trial is to estimate the maximum tolerated dose, MTD, of a new drug. In this paper, the MTD estimation method is suggested by curve fitting the dose-toxicity data to an S-shaped curve. The suggested MTD estimation method is compared with established MTD estimation procedures using a Monte Carlo simulation study.

A Ship Intelligent Anti-Collision Decision-Making Supporting System Based On Trial Manoeuvre

  • Zhuo, Yongqiang;Yao, Jie
    • Proceedings of the Korean Institute of Navigation and Port Research Conference
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    • 2006.10a
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    • pp.176-183
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    • 2006
  • A novel intelligent anti-collision decision-making supporting system is addressed in this paper. To obtain precise anti-collision information capability, an innovative neurofuzzy network is proposed and applied. A fuzzy set interpretation is incorporated into the network design to handle imprecise information. A neural network architecture is used to train the parameters of the Fuzzy Inference System (FIS). The learning process is based on a hybrid learning algorithm and off-line training data. The training data are obtained by trial manoeuvre. This neurofuzzy network can be considered to be a self-learning system with the ability to learn new information adaptively without forgetting old knowledge. This supporting system can decrease ship operators' burden to deal with bridge data and help them to make a precise anti-collision decision.

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Trial Installation and Performance Evaluation of Prefabricated Concrete Slab Track on Revenue Line (프리캐스트 콘크리트 슬래브궤도의 영업선 시험시공 및 성능평가)

  • Jang, Seung-Yup;Kang, Yun-Suk;Lee, Hu-Sam;Kim, Yu-Bong;Lee, Jong-Soo
    • Proceedings of the KSR Conference
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    • 2008.11b
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    • pp.840-845
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    • 2008
  • To develop our original technology of concrete slab track, being widely accepted for new track, prefabricated concrete slab track, or precast concrete slab track has been developed. They have two different types according to slab shape and its dimensions, connection of slabs and connecting structure onto substructure. After the system design and successful performance evaluation in the laboratory, the trial installation on revenue line has been carried out. This paper is presenting the result of the trial installation and the performance tests in field. The performance tests have been performed as visual inspection for cracks and damages, measurement of track alignment and elastic behavior of track under passing trains. The performance test results during last 2 years have shown that no remarkable damages and settlements were found, and track alignment and elastic track behavior both exhibits good status.

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Utility of Integrated Analysis of Pharmacogenomics and Pharmacometabolomics in Early Phase Clinical Trial: A Case Study of a New Molecular Entity

  • Oh, Jaeseong;Yi, Sojeong;Gu, Namyi;Shin, Dongseong;Yu, Kyung-Sang;Yoon, Seo Hyun;Cho, Joo-Youn;Jang, In-Jin
    • Genomics & Informatics
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    • v.16 no.3
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    • pp.52-58
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    • 2018
  • In this report, we present a case study of how pharmacogenomics and pharmacometabolomics can be useful to characterize safety and pharmacokinetic profiles in early phase new drug development clinical trials. During conducting a first-in-human trial for a new molecular entity, we were able to determine the mechanism of dichotomized variability in plasma drug concentrations, which appeared closely related to adverse drug reactions (ADRs) through integrated omics analysis. The pharmacogenomics screening was performed from whole blood samples using the Affymetrix DMET (Drug-Metabolizing Enzymes and Transporters) Plus microarray, and confirmation of genetic variants was performed using real-time polymerase chain reaction. Metabolomics profiling was performed from plasma samples using liquid chromatography coupled with quadrupole time-of-flight mass spectrometry. A GSTM1 null polymorphism was identified in pharmacogenomics test and the drug concentrations was higher in GSTM1 null subjects than GSTM1 functional subjects. The apparent drug clearance was 13-fold lower in GSTM1 null subjects than GSTM1 functional subjects (p < 0.001). By metabolomics analysis, we identified that the study drug was metabolized by cysteinylglycine conjugation in GSTM functional subjects but those not in GSTM1 null subjects. The incidence rate and the severity of ADRs were higher in the GSTM1 null subjects than the GSTM1 functional subjects. Through the integrated omics analysis, we could understand the mechanism of inter-individual variability in drug exposure and in adverse response. In conclusion, integrated multi-omics analysis can be useful for elucidating the various characteristics of new drug candidates in early phase clinical trials.

Design of Course Keeping Controller for RIB-type USV Using a Pilot's Steering Pattern (조종자 입력패턴을 활용한 RIB형 무인선의 침로제어기 설계)

  • Yun, Kun-Hang;Yeo, Dong-Jin;Yoon, Hyeon-Kyu
    • Journal of the Society of Naval Architects of Korea
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    • v.47 no.3
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    • pp.462-468
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    • 2010
  • A new course keeping controller for RIB(Rigid Inflatable Boat)-type USV(Unmanned Surface Vehicle) is developed using pilot's steering pattern. A pilot's simple steering pattern is found out from various course change tests. It is used to course keeping algorithm, suitable for large course change more than 60 degrees. To validate the course keeping controller, sea trial tests are conducted. From sea trial test, new course keeping controller shows good performance with less overshoot, maximum roll angle less than $20^{\circ}$, which makes it possible that fast course changes without slip motion of USV.

A Case Study on the Capacity Design for Manufacturing Process of Bearing-Race (베어링궤도 제조공정의 용량설계에 관한 사례연구)

  • Moon, Dug-Hee;Song, Cheng
    • IE interfaces
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    • v.15 no.4
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    • pp.349-355
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    • 2002
  • In order to build a new factory, we must have answers regarding the following questions; 1. what is to be produced? 2. how are the products to be produced? 3. how much of each product will be produced? The answers are related to product-design, process-design and capacity-design respectively and they are used for layout-design as the input data. Especially capacity design decision provides the information regarding the number of equipments required and the balance of the line. This paper introduces a case study on the capacity design for a new factory where the retainers of ball bearing are manufactured. A simulation model is developed with ARENA for analyzing the system considered. The major objectives of the study are evaluating the performance of the line which is originally suggested by the company, and finding out alternatives for improving the system. Number of WIP between the processes are also investigated because it affects the space planning of the layout.

Development of Optimization Algorithm for Unconstrained Problems Using the Sequential Design of Experiments and Artificial Neural Network (순차적 실험계획법과 인공신경망을 이용한 제한조건이 없는 문제의 최적화 알고리즘 개발)

  • Lee, Jung-Hwan;Suh, Myung-Won
    • Transactions of the Korean Society of Mechanical Engineers A
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    • v.32 no.3
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    • pp.258-266
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    • 2008
  • The conventional approximate optimization method, which uses the statistical design of experiments(DOE) and response surface method(RSM), can derive an approximated optimum results through the iterative process by a trial and error. The quality of results depends seriously on the factors and levels assigned by a designer. The purpose of this study is to propose a new technique, which is called a sequential design of experiments(SDOE), to reduce a trial and error procedure and to find an appropriate condition for using artificial neural network(ANN) systematically. An appropriate condition is determined from the iterative process based on the analysis of means. With this new technique and ANN, it is possible to find an optimum design accurately and efficiently. The suggested algorithm has been applied to various mathematical examples and a structural problem.

Development of a New NC-Controlled Trial Manufacturing Process for Sheet Metal Forming (박판 형성을 위한 새로운 추치 제어식 시작 방법의 개발)

  • 조철훈;양동열
    • Proceedings of the Korean Society of Precision Engineering Conference
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    • 1995.10a
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    • pp.929-932
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    • 1995
  • In the work, a new computerized incremental forming method having high flexibility has been developed. In the mothod, the ordinary tools are replaced by various small tools, and only the small local region of a sheet blank is incrementally by movement of these tools. Since a small tool moves over the arbitrary surface ofthe dies using a NC machine, it is possible to produce three-dimensional and non-symmetric parts directly from CAD data. Arbitrarily shaped dies are made by LOM(Laminated Object Manufacturing), which is one of the Rapid Prototyping Methods. A forming machine is designed and developed by introducing a computer to control the movement of the tools.

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A new two-state randomized response model (새로운 2단계 확률화응답모형)

  • 김종호;류제복;이기성
    • The Korean Journal of Applied Statistics
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    • v.5 no.2
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    • pp.157-167
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    • 1992
  • This paper presents a new two-stage randomized response model to protect greater privacy of respondents for the sensitive characters. The conditions when the proposed model will be more efficient than Warner model, Liu-Chow's multiple trial model and Mangat-Singh model have been obtained for the case when the respondents are truthful in their answer, and the efficiency of the proposed model is also compared with Warner model, Liu-Chow's multiple trial model and Mangat-Singh model.

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Review of Ethical and Scientific Aspects of Acupuncture Clinical Trials Pointed Out by Institutional Review Board a Part of Development Process of the Acupuncture and Moxibustion Clinical Research Guideline (침구임상시험 가이드라인 개발과정에서 IRB의 윤리적·과학적 지적사항 사례 조사 연구)

  • Leem, Jung Tae;Lee, Seung Hoon;Han, Ga Jin;Kim, Eun Jung;Seo, Byung Kwan;Kim, Tae Hun;Lee, Seung Deok;Kim, Jong Uk;Yu, A Mi;Nam, Dong Woo;Lee, Jun Hee
    • Journal of Acupuncture Research
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    • v.32 no.2
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    • pp.11-21
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    • 2015
  • Objectives : To improve quality of clinical research for acupuncture and moxibustion, a guideline for clinical research protocol is needed. While developing a guideline for acupuncture and moxibustion clinical research, we reviewed the ethical and scientific aspects of protocols pointed out by the institutional review board. This will offer practical assistance to the researchers. Methods : Ethical and scientific aspects of acupuncture and moxibustion research protocols reviewed by Kyung Hee University Korean Medicine Hospital Institutional Review Board were gathered and reviewed. Results : Ethical and scientific aspects of protocol review was reported. Conclusions : The example of review will be helpful for new researchers when developing acupuncture and moxibustion clinical research protocol.